MAUDE Adverse Event Report: MEDTRONIC MEXICO AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number ATL2001

Device Problem Obstruction of Flow (2423)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 01/16/2024

Event Type  Death  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of el reservoirs and an autolog wash kit , it was reported that the procedure commenced at 15:10pm and patient deceased at 19:50pm.The customer stated that at approximately 17:00h the patient began bleeding profusely, the customer estimated approximately 800mls of autologous blood had been processed and collected without incident up to this time and returned to the patient.The customer reported that once the patient began bleeding heavily the acda (citrate anticoagulant) drip rate was increased so that it was flowing continuously and the clamp was fully open to assist with anticoagulation of the salvaged blood.The customer stated that at approximately 17:00 hours surgicel was used within the sterile field and suctioned into the cell saver and froth was observed in the reservoir.The reservoir was changed out and the second reservoir was also discarded when froth was again observed.A third reservoir and second wash kit were installed.Fibrinogen concentrate, platelets (unknown number) and 18 units of allogenic packed cells were administered in total.The customer observed that the blood in the third reservoir was observed to be clotting post reservoir filter,  however the auto-transfusionist attempted to process the blood.In total 18 bags of acda citrate was used to attempt to avoid clotting of the salvaged blood.The processed blood was not able to be reinfused into the patient due to the lipiguard filters and the bellmont filter blocking.The customer observed a clot in the reinfusion bag and the blood was discarded.Approximately 3.5l of salvaged blood was unable to be processed.  the patients hb at 18:20pm was 61 and at 17:40pm it was 12.The patient arrested at approximately 19:15pm and at this time the central line was dislodged when the ivc tore as a result of chest compressions.The main concern from the customer was in relation to the cell saver's inability to achieve anticoagulation of the salvaged blood and the fact that the wash kit processed some of the clot material and pumped it up into the reinfusion bag.  see attached photos.The devices were replaced to complete the procedure.There was patient death associated with hypovolemic cardiac arrest.Elective open r) nephrectomy + liver/diaphragm resection medtronic received additional information that the patient's death is not linked to the performance of el reservoirs and an autolog wash kit.The confusion surrounds the reason for the inability to adequately anticoagulate the patient to avoid clotting.The bubbles/foam was observed at the top of the reservoir - when looking down into the reservoir.There was no venous line - it was not a cardiac procedure.There was no temperature pre and post oxygenation as no oxygenator was used.Fibrin grew quickly after the fibrinogen was administered.Anticoagulant citrate dextrose solution was the only anticoagulant used.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AUTOLOG WASH KIT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18675016
• MDR Text Key: 334950560
• Report Number: 9612164-2024-00689
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 227395168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Date Device Manufactured: 09/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Sex: Male
• Patient Weight: 94 KG